Efficacy and Safety of Chronic Administration of Telmisartan as Monotherapy or in Combination With Hydrochlorothiazide or Other Antihypertensive Medications in Patients With Mild to Moderate Hypertension

NCT02177422 | Completed Phase 3

• 1 other identifier: 502.260
• Study Type: interventional
• Target: 489
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this trial was to assess the efficacy and safety of telmisartan 80 mg during open-label, long-term treatment. An additional objective was to assess the efficacy and safety of concomitant administration of telmisartan 80 mg and HCTZ (Hydrochlorothiazide) and/or any other therapies commonly used in the treatment of hypertension.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (10)

• Achievement of goal blood pressure response defined by a mean sitting diastolic blood pressure <90 mmHg

  Up to one year

• Need for addition of hydrochlorothiazide or subsequent change in antihypertensive therapy

  Up to one year

• Time to addition of hydrochlorothiazide or any subsequent change in antihypertensive therapy

  Up to one year

• Mean sitting diastolic blood pressure during each visit

  At months 3, 6, 9, 12

• Mean sitting systolic blood pressure during each visit

  At months 3, 6, 9, 12

• Number of patient with adverse events

  Up to one year

• Changes from baseline in heart rate

  Baseline and at months 3, 6, 9, 12

• Number of patients with abnormal changes in 12-Lead ECG (electrocardiogram)

  Baseline and 12 months

• Number of patients with abnormal changes in laboratory parameters

  Baseline and 12 months

• Number of patients with abnormal findings in physical examination

  Baseline and at 12 month

Study Arms (1)

Telmisartan

EXPERIMENTAL

Drug: Telmisartan; Drug: Hydrochlorothiazide

Interventions

Telmisartan DRUG

telmisartan 80 mg once daily

Telmisartan

Hydrochlorothiazide DRUG

12.5 mg or 25 mg Hydrochlorothiazide in addition to telmisartan in case that the goal response (mean sitting diastolic blood pressure \< 90 mmHg) is not met after at least 4 weeks of treatment with telmisartan

Telmisartan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild-to-moderate essential hypertension defined as a mean seated diastolic blood pressure measurement of ≥ 95 mmHg measured by manual cuff sphygmomanometer
• Mean seated systolic blood pressure ≥ 140 mmHg, measured my manual cuff
• A 24-hour mean diastolic blood pressure, measured by ABPM (ambulatory blood pressure measurement), of ≥ 85 mmHg
• Age 18 or older
• Patient's written informed consent in accordance with GCP (Good Clinical Practice) and local legislation

You may not qualify if:

• Patients with a clinically significant change in ECG from baseline that was reported as an adverse event during the preceding clinical trial
• Patients who have developed a medical condition during the preceding clinical trial that, in the investigator's opinion, may be worsened by treatment or may compromise the safety evaluation of telmisartan
• Patients who discontinued the preceding telmisartan clinical trial due to an adverse event
• Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 1998
• Primary Completion: November 1, 1999
• Last Updated: July 8, 2014

Record last verified: 2014-07